A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES) (RCT)
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|ClinicalTrials.gov Identifier: NCT02698839|
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: BuMA Supreme Device: BuMA™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||539 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective, Multicenter Trial Program in China to Evaluate the Efficacy and Safety of BuMA Supreme (eG Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Patients With de Novo Coronary Lesions, RCT Trial|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2023|
Experimental: BuMA Supreme group
This group contains 319 subjects. Among them, 220 subjects will be implanted with regular specifications and 99 subjects with narrower, wider or longer ones.
Device: BuMA Supreme
Stent platform: cobalt-chromium alloy
Active Comparator: BuMA™ group
This group contains 220 subjects.
Stent platform: stainless steel
- in-stent Late Lumen Loss, 9M [ Time Frame: QCA at 9-month follow-up window ]The primary endpoint is in-stent Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).
- Stent implantation success rate [ Time Frame: 5 years after PCI ]The stent implantation success rate includes device success, lesion success and clinical success.
- Binary restenosis rate [ Time Frame: 9 months ]Binary restenosis was defined in every segment (proximal, distal, and stent) as a >50% diameter.
- in-segment LLL [ Time Frame: 9 months ]to evaluate the in-sigment Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).
- diameter stenosis degree [ Time Frame: 9 months ]to compare the lumen diameter at 9-month after stent implantation with the baseline diameter as assessed by off-line quantitative coronary angiography (QCA).
- Device-oriented Composite Endpoint (DoCE) [ Time Frame: 1, 6, 12 month, and annually up to 5 years post procedure ]Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR).
- Patient-oriented Composite Endpoint (PoCE) [ Time Frame: 1, 6, 12 month, and annually up to 5 years post procedure ]Patient-oriented Composite Endpoint is defined as all cause death, all myocardial ischemia (MI), or any revascularization.
- Academic Research Consortium(ARC) defined stent thrombosis [ Time Frame: 5 years after PCI ]Definite and probable stent thrombosis during acute, subacute, later and very late phase.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698839
|Contact: Junbo Ge, Ph.D.||+86-021-64041990 ext firstname.lastname@example.org|
|Contact: Lei Ge, Ph.D.||email@example.com|
|Shanghai, China, 200032|
|Contact: Junbo Ge, Ph.D +86-021-64041990 ext 2745 firstname.lastname@example.org|
|Principal Investigator:||Junbo Ge, Ph.D.||Shanghai Zhongshan Hospital|
|Principal Investigator:||Yundai Chen, Ph.D.||The General Hospital of PLA (301 hospital)|
|Principal Investigator:||Shaoping Nie, Ph.D.||Bejing Anzhen Hospital|
|Principal Investigator:||Shubin Qiao, Ph.D.||Fu Wai Hospital|
|Principal Investigator:||Yawei Xu, Ph.D.||Shanghai 10th People's Hospital|
|Principal Investigator:||Bo Yu, Ph.D.||The 2th Affiliated Hospital of Harbin Medical University|